Manager, Regulatory Medical Writing, X-TA

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Medical Affairs Group

Job Sub Function:
Medical Writing

Job Category:
Professional

All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Manager, Regulatory Medical Writing to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business.

The position may be located High Wycombe, UK; Leiden, Netherlands; Neuss, Germany; Paris, France; or Beerse, Belgium.

The position is Hybrid (3 days onsite weekly).

Remote work options may be considered on a case-by-case basis and if approved by the company.

Are you ready to join our team? Then please read further!

You will be responsible for:



* Preparing and finalizing all types of clinical documents.


* Leading in a team environment.

Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking.


* Leading or setting objectives for others on team projects and tasks, eg, leading process working groups.


* Guiding or training cross-functional team members on processes and best practices.


* Potentially leading project-level/submission/indication writing teams.


* Proactively providing recommendations for departmental process improvements.


* If a lead writer for a program: Primary point of contact and champion for medical writing activities for the clinical team.

Responsible for planning and leading the writing group for assigned program.


* Actively participating in medical writing and cross-functional meetings.


* Maintaining knowledge of industry, company, and regulatory guidelines.


* Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed; overseeing the work of other medical writers, external contractors, and document specialists supporting a project.


* Interacting with senior cross-functional colleagues to streng...